Common use of Participant Visit Fees Clause in Contracts

Participant Visit Fees. [Insert content in the “Clinical Trial Participant Visit Fees” section of the iCT export here.] All Other Fees [Insert content in the “All Other Fees” section of the iCT export here.] Appendix 5 – Conditions Applicable to the Principal Investigator The Principal Investigator is free to participate in the Clinical Trial and there are no rights that may be exercised by, or obligations owed to, any third party that may prevent or restrict the performance by the Principal Investigator of the obligations set out in the Agreement. Where the Trial Site is not the Principal Investigator’s substantive employer, the Principal Investigator must notify their substantive employer of the proposed participation in the Clinical Trial and where relevant, the supervision of Personnel, and further, the Principal Investigator must have obtained consent from the substantive employer for participation in the Clinical Trial. The Principal Investigator is not the subject of any regulatory litigation or misconduct litigation or investigation. No data produced by the Principal Investigator in any other clinical trial has been rejected because of concerns as to its accuracy or because it was generated by fraudulent means. The Principal Investigator has considered and is satisfied that facilities appropriate to the Clinical Trial are available at the Trial Site, and any Other Trial Site(s), and that in the performance of obligations under this Agreement, is satisfied that they will be supported by medical and other staff of sufficient number and experience to enable the Trial Site, and any Other Trial Site(s), to perform the Clinical Trial efficiently and in accordance with the obligations under this Agreement. Where the Trial Site is not the Principal Investigator’s substantive employer, and the Principal Investigator is not a partner at the Trial Site, the Principal Investigator holds a contract for services (commonly known as an honorary contract) with the Trial Site. During the Clinical Trial, the Principal Investigator will not serve as principal investigator or sub-investigator in any clinical trial for another sponsor if such activity may adversely affect the ability of the Principal Investigator to perform their obligations under this Agreement. The Principal Investigator and Personnel carry medical liability insurance, or are otherwise covered by an equivalent NHS scheme, and the details and evidence of the coverage will be provided to the Sponsor upon request.

Participant Visit Fees. [Insert content in the “Clinical Trial Participant Visit Fees” section of the iCT export here.] All Other Fees [Insert content in the “All Other Fees” section of the iCT export here.] Appendix 5 3 – Conditions Applicable to the Principal Investigator The Principal Investigator is free to participate in the Clinical Trial Non-Interventional Study and there are no rights that may be exercised by, or obligations owed to, any third party that may prevent or restrict the performance by the Principal Investigator of the obligations set out in the Agreement. ; Where the Trial Site Participating Organisation is not the Principal Investigator’s substantive employer, the Principal Investigator must notify their substantive employer of the proposed participation in the Clinical Trial Non-Interventional Study and where relevant, the supervision of Personnel, and further, the Principal Investigator must have obtained consent from the substantive employer for participation in the Clinical Trial. Non-Interventional Study; The Principal Investigator is not the subject of any regulatory litigation or misconduct litigation or investigation. No data produced by the Principal Investigator in any other clinical trial study has been rejected because of concerns as to its accuracy or because it was generated by fraudulent means. ; The Principal Investigator has considered and is satisfied that facilities appropriate to the Clinical Trial Non-Interventional Study are available at the Trial Site, and any Other Trial Site(s), Participating Organisation and that in the performance of obligations under this Agreement, is satisfied that they will be supported by medical and other staff of sufficient number and experience to enable the Trial Site, and any Other Trial Site(s), Participating Organisation to perform the Clinical Trial Non-Interventional Study efficiently and in accordance with the obligations under this Agreement. ; Where the Trial Site Participating Organisation is not the Principal Investigator’s substantive employer, and the Principal Investigator is not a partner at the Trial Site, the Principal Investigator holds a contract for services (commonly known as an honorary contract) with the Trial Site. Participating Organisation; During the Clinical TrialNon-Interventional Study, the Principal Investigator will not serve as principal investigator or sub-investigator in any clinical trial study for another sponsor if such activity may adversely affect the ability of the Principal Investigator to perform their obligations under this Agreement. ; The Principal Investigator and Personnel carry Participating Organisation carries medical liability insuranceinsurance covering the Principal Investigator, or are is otherwise covered by an equivalent NHS scheme, and the details and evidence of the coverage will be provided to the Sponsor upon request.

Participant Visit Fees. [Insert content in the “Clinical Trial Participant Visit Fees” section of the iCT export here.] All Other Fees [Insert content in the “All Other Fees” section of the iCT export here.] Appendix 5 – Conditions Applicable to the Principal Investigator The Principal Investigator is free to participate in the Clinical Trial and there are no rights that may be exercised by, or obligations owed to, any third party that may prevent or restrict the performance by the Principal Investigator of the obligations set out in the Agreement. Where the Trial Site is not the Principal Investigator’s substantive employer, the Principal Investigator must notify their substantive employer of the proposed participation in the Clinical Trial and where relevant, the supervision of Personnel, and further, the Principal Investigator must have obtained consent from the substantive employer for participation in the Clinical Trial. The Principal Investigator is not the subject of any regulatory litigation or misconduct litigation or investigation. No data produced by the Principal Investigator in any other clinical trial has been rejected because of concerns as to its accuracy or because it was generated by fraudulent means. The Principal Investigator has considered and is satisfied that facilities appropriate to the Clinical Trial are available at the Trial Site, and any Other Trial Site(s), and that in the performance of obligations under this Agreement, is satisfied that they will be supported by medical and other staff of sufficient number and experience to enable the Trial Site, and any Other Trial Site(s), to Site(s),to perform the Clinical Trial efficiently and in accordance with the obligations under this Agreement. Where the Trial Site is not the Principal Investigator’s substantive employer, and the Principal Investigator is not a partner at the Trial Site, the Principal Investigator holds a contract for services (commonly known as an honorary contract) with the Trial Site. During the Clinical Trial, the Principal Investigator will not serve as principal investigator or sub-investigator in any clinical trial for another sponsor if such activity may adversely affect the ability of the Principal Investigator to perform their obligations under this Agreement. The Principal Investigator and Personnel carry Trial Site carries medical liability insuranceinsurance covering the Principal Investigator, or are is otherwise covered by an equivalent NHS scheme, and the details and evidence of the coverage will be provided to the Sponsor upon request.

Participant Visit Fees. [Insert content in the “Clinical Trial Participant Visit Fees” section of the iCT export here.] All Other Fees [Insert content in the “All Other Fees” section of the iCT export here.] Appendix 5 – Conditions Applicable to the Principal Investigator The Principal Investigator is free to participate in the Clinical Trial Investigation and there are no rights that may be exercised by, or obligations owed to, any third party that may prevent or restrict the performance by the Principal Investigator of the obligations set out in the Agreement. Where the Trial Site is not the Principal Investigator’s substantive employer, the Principal Investigator must notify their substantive employer of the proposed participation in the Clinical Trial Investigation and where relevant, the supervision of Personnel, and further, the Principal Investigator must have obtained consent from the substantive employer for participation in the Clinical TrialInvestigation. The Principal Investigator is not the subject of any regulatory litigation or misconduct litigation or investigation. No data produced by the Principal Investigator in any other clinical trial study has been rejected because of concerns as to its accuracy or because it was generated by fraudulent means. The Principal Investigator has considered and is satisfied that facilities appropriate to the Clinical Trial Investigation are available at the Trial Site Site, and any Other Trial Site(s)Sites, and that in the performance of obligations under this Agreement, is satisfied that they will be supported by medical and other staff of sufficient number and experience to enable the Trial Site, and any Other Trial Site(s), to perform the Clinical Trial Investigation efficiently and in accordance with the obligations under this Agreement. Where the Trial Site is not the Principal Investigator’s substantive employer, and the Principal Investigator is not a partner at the Trial Site, the Principal Investigator holds a contract for services (commonly known as an honorary contract) with the Trial Site. During the Clinical TrialInvestigation, the Principal Investigator will not serve as principal investigator or sub-investigator in any clinical trial study for another sponsor if such activity may adversely affect the ability of the Principal Investigator to perform their obligations under this Agreement. The Principal Investigator and Personnel carry Trial Site carries medical liability insuranceinsurance covering the Principal Investigator, or are is otherwise covered by an equivalent NHS scheme, and the details and evidence of the coverage will be provided to the Sponsor upon request.

Participant Visit Fees. [Insert content in the “Clinical Trial Participant Visit Fees” section of the iCT export here.] All Other Fees [Insert content in the “All Other Fees” section of the iCT export here.] Appendix 5 2 – Conditions Applicable Other Trial Site Duties as required by the Protocol and instructed by the Lead Trial Site “Work Plan” [This section has been left blank to be agreed and completed between the Parties. Please note that where duties include the transfer of any clinical biological sample, or portion thereof derived from Participants “Material”, Appendix 4 should be adhered to. Where the Other Trial Site is agreeing any task within this Work Plan, they are confirming that they are adhering to appropriate legislation and Clinical Governance, they have the suitable facilities, staffing, expertise and licensing to complete the Work Plan, and have and receive the appropriate training e.g. GCP, Clinical Trial specific, Immunology etc. For ease, please divide Appendix 2 into 3 sections headed: Screening, Dosing and Follow Up and in a numbered list, list all the agreed tasks required in the Work Plan.] The following is an example which may be used: Set up/close down Other Trial Site will: release relevant Other Trial Site Personnel as applicable to attend weekly planning and set up meetings with the Principal Investigator and the Lead Trial Site team ahead of the planned study date according to a standard agenda; provide to the Principal Investigator The Principal Investigator is free and the Lead Trial Site team a weekly record, and report planning progress working with the Lead Trial Site team to participate in the plan and implement Clinical Trial set up and there are no rights close down as per the Protocol; share information and documentation with the Lead Trial Site that may be exercised by, or obligations owed to, any third party that may prevent or restrict is required to support confirmation of capacity and capability by the performance by Lead Trial Site; ensure Other Trial Site Personnel complete all required Clinical Trial related and professional training; assure the Principal Investigator of the obligations set out in the Agreement. Where the overall Clinical Trial conduct of processes and Other Trial Site is not Personnel at the Other Trial Site; ensure Other Trial Site Personnel demonstrate clear understanding of the Protocol, and read and understand Investigator’s Brochure (IB) including potential risks and side effects of the IMP/device, according to the role and responsibilities of each Other Trial Site Personnel within the Clinical Trial team, and as confirmed by the delegation log signed by the Principal Investigator’s substantive employer; in accordance with the Protocol, the Principal Investigator must notify their substantive employer and required as part of the proposed participation in delegated roles and responsibilities within the Clinical Trial and where relevantdelegation log, the supervision of Personnel, and further, the Principal Investigator must ensure all required EC/IRB reviewed documents that have obtained consent from the substantive employer for participation in the Clinical Trial. The Principal Investigator is not the subject of any regulatory litigation or misconduct litigation or investigation. No data produced subsequently been reviewed by the Principal Investigator in any other clinical trial has been rejected because of concerns as are read, understood and implemented/actioned. At a minimum these documents will include: Protocol, Protocol amendments and administrative changes Informed consent(s) and all revisions Communications and advertisements, written information to its accuracy be provided to the Participants Investigator Brochure & all IND safety reports Serious Adverse Events Deviations/Violations/Exemptions Annual reports file all Clinical Trial documentation and related correspondence within the Lead Trial Investigator Site File held by the Lead Trial Site; ensure records are available for routine monitoring and inspection by Sponsor, CRO or because it was generated by fraudulent means. The regulatory authorities; inform the Principal Investigator and CRO immediately of any pending regulatory inspection; ensure that the Other Trial Site Personnel are available for monitoring visits; attend all Clinical Trial related meeting required by Principal Investigator and Sponsor. Location management Other Trial Site will: identify and agree a location or locations for Clinical Trial delivery with the Lead Trial Site and the Principal Investigator; provide assurance that the location or locations is/are compliant with Health and Safety and security and infection prevention and control policies and standards; ensure the Other Trial Site is specifically and sufficiently mitigated in relation to cyber and anti vax protester security risks; provide adequate equipment and facilities, prepared and fit for purpose for the delivery of the proposed Clinical Trial to comply with the Protocol specification; ensure the Other Trial Site has considered appropriate Information Technology software, hardware and technical support; ensure the Other Trial Site has contact telephone numbers for relevant Clinical Trial- related information; provide name and contact information for an operational/research delivery single point of contact and at least one member of Personnel at the Other Trial Site; ensure the Other Trial Site has adequate car parking, access and participant flow capacity to support the delivery of the Protocol. Screening and dosing and follow up Other Trial Site will: work with the Lead Trial Site to identify eligible Participants for the Clinical Trial; monitor and report screening attendance and screen failures as directed by the Principal Investigator and Sponsor; identify Personnel to manage and assure the Principal Investigator of documented accountability of all IMP and supplies according to Protocol and related SOPs; provide a clinic schedule that is satisfied that facilities appropriate accessible to the target Clinical Trial are available at population; verify identification of all Participants attending for any Clinical Trial visit; obtain informed consent and deliver all Clinical Trial- visit related activities according to the Protocol; maintain adequate and accurate records including clinic attendance and all Protocol procedures; ensure data in eCRFs can be verified/signed-off in line with documented information in the source documents; provide safety reports to the Principal Investigator for assessment of causality within the timelines stated within the Protocol; report all Serious Adverse Events to the Principal Investigator; assess and notify the Principal and Sponsor of GCP breaches; report Clinical Trial Site, performance data and any monitor research delivery to time and target; Escalate issues around RTT to facilitate resolution. Unscheduled events Other Trial Site(s), Site will: provide out of hours medical telephone cover as defined by the Protocol and that as delegated by the Principal Investigator. Manage unscheduled events as stated in the performance of obligations under this Agreement, is satisfied that they will be supported by medical and other staff of sufficient number and experience to enable Protocol; identify a location within the Trial Site, and any Other Trial Site(s), to perform Site suitable for the Clinical Trial efficiently and delivery of unscheduled visits in accordance with the obligations under this Agreement. Where Participants needs and Protocol requirements; provide a mechanism for home visits as defined by the Protocol and / or identified by the Lead Trial Site is not or Sponsor; maintain adequate and accurate records including unscheduled clinic attendance and all unscheduled Protocol procedures; ensure data in eCRFs can be verified/signed-off in line with documented information in the source documents; provide safety reports to the Principal Investigator for assessment of causality within the timelines stated within the Protocol; report all Serious Adverse Events to the Principal Investigator’s substantive employer, and the Principal Investigator is not a partner at the Trial Site, the Principal Investigator holds a contract for services (commonly known as an honorary contract) with the Trial Site. During the Clinical Trial, the Principal Investigator will not serve as principal investigator or sub-investigator in any clinical trial for another sponsor if such activity may adversely affect the ability of the Principal Investigator to perform their obligations under this Agreement. The Principal Investigator and Personnel carry medical liability insurance, or are otherwise covered by an equivalent NHS scheme, and the details and evidence of the coverage will be provided to the Sponsor upon request.